Roche chalks up second approval for Gazyva

FDA approves additional indication as a treatment for
follicular lymphoma

Roche has been granted FDA approval for a second indication for slow-growing leukaemia drug Gazyva, giving it the nod as a treatment for follicular lymphoma.

Gazyva (obinutuzumab) - sold as Gazyvaro in Europe - was first introduced for the treatment of chronic lymphocytic leukaemia (CLL) in the US towards the end of 2013 and was approved in the EU last year.

The CD20-targeting antibody brought in sales of CHF 128m ($128m) last year, with uptake pegged back by competitive pressure in the CLL market and the slow pace of reimbursement approvals in Europe. When first launched, analysts predicted sales of $1.5bn to $2.5bn for the drug at peak.

Follicular lymphoma is a subtype of non-Hodgkin's lymphoma (NHL) - accounting for around a fifth of all NHL cases - and is a much larger patient population than CLL, which has seen a string of new products enter the market such as Johnson & Johnson's first-in-class BTK inhibitor Imbruvica (ibrutinib) and Gilead Sciences' Zydelig (idelalisib).

The drug is in the same class as Roche's blockbuster anti-CD20 antibody MabThera/Rituxan (rituximab) but has been designed with sugar molecule side chains that improve its therapeutic and safety profile in the body.The follicular lymphoma indication gives Roche the opportunity to accelerate the growth of the drug, which it sees as the cornerstone of a number of therapies for haematological cancers.

It has been approved for use alongside bendamustine chemotherapy - followed by Gazyva alone - as a new treatment for people with follicular lymphoma who did not have a successful outcome with Rituxan treatment.The approval is based on results from the Phase III GADOLIN study, which showed that the Gazyva regimen achieved a 52% reduction in the risk of disease worsening or death compared to bendamustine alone in this group.

Gazyva is also in trials as a monotherapy and alongside other agents for first-line, indolent NHL as well as diffuse large B-cell lymphoma (DLBCL), which according to Roche will significantly increase the number of patents eligible for treatment with the drug.

The company has particularly high expectations for the combination of Gazyva with AbbVie-partnered BCL-2 inhibitor venetoclax in CLL and NHL.